Retractor apparatus and methods for use

ABSTRACT

Trocar retractor apparatus and methods for use are described where an apparatus for positioning an instrument may generally include a substrate having a first surface and a second surface opposite to the first surface, an instrument positioning guide projecting from the first surface of the substrate, and one or more suction assemblies positioned along the second surface and in fluid communication with an interior of the substrate. The one or more suction assemblies may be attachable to a tissue region via a vacuum force applied through the one or more suction assemblies. The apparatus may also have the substrate configured to maintain a predetermined configuration when the vacuum force is applied.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Prov. App.62/948,050 filed Dec. 13, 2019, which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods.More particularly, the present invention relates to apparatus andmethods for the positioning of trocar devices and tissue regions.

BACKGROUND OF THE INVENTION

Trocars are typically used for surgical procedures, such as laparoscopicprocedures, in order to gain access to interior body lumens through theskin surface. Generally, the trocar includes an obturator which may beblunt or sharpened which may be inserted through a hollow cannula. Byinserting the trocar through the skin surface and into the body lumen,such as an abdominal cavity, the obturator may be removed from thecannula leaving an access pathway through the cannula and into the bodylumen. Unfortunately, trocars typically do not provide any indication oftrocar penetration depth to the user who must estimate the penetrationdepth during and after penetration of the abdominal wall.

Furthermore, trocar insertion can lead to a perforating puncture woundof an underlying organ or structure resulting in a medical complication.For instance, laparoscopic intra-abdominal trocar insertion can lead toinjury of the underlying bowels or to hemorrhaging of various bloodvessels. This is further complicated by the tendency of the tissue tocollapse or depress around the trocar when the trocar is inserted intothe tissue.

To reduce the incidence of unintentional perforation, surgeons mayestablish a pneumoperitoneum by insufflating the abdomen with a gas toexpand the space between the interior of the abdominal wall andunderlying internal organs with the intention of providing a space for atrocar to penetrate through the abdominal wall and above the organs. Thepneumoperitoneum is typically established through the use of a Veressneedle which is used to penetrate the abdominal cavity and deliver thegas but the needle also has the same potential complications as trocarinsertion.

Once penetration of the body wall has been attained, the obturator maybe removed, leaving a cannula penetrating the body adapted to receiveany number of surgical instruments. However, the guide tube may besubject to unintentional or undesirable movements such as changes inpenetration depth or accidental withdrawal from the body.

Therefore, there exists a need for an insufflation/trocar device whichcan be inserted safely into a patient body with a reduced risk ofunderlying tissue injury. There is also a need for devices which allowfor the positioning and retraction of tissue regions during procedureswithout risk of injury or inadvertent movement.

SUMMARY OF THE INVENTION

One variation of a trocar positioning platform which may also be usedfor tissue retraction or positioning. The positioning platform mayinclude a substrate having a first side upon which a trocar positioningguide may extend and a second side which is configured to apply areleasable vacuum through one or more suction openings which may beadhered upon a tissue surface for temporary securement. A pump ornegative pressure mechanism located remotely from the substrate may befluidly coupled to the substrate via one or more fluid lines forproviding the vacuum force. The one or more suction openings may bedistributed over the substrate in a uniform manner, an arbitrary manner,or in any number of predetermined specified configurations. The one ormore suction openings may each define a chamber defined by an individualsuction assembly. While the number of suction openings may vary from oneto a plurality of openings, one variation of the substrate mayincorporate, e.g., twenty-one to twenty-five suction openings.

The substrate may be formed to have any variety of configurations (e.g.,circular, elliptical, rectangular, pentagonal, hexagonal, octagonal,etc.) so long as the substrate is desirably positionable upon a tissueregion of interest. While the substrate may be formed in a number ofdifferent configurations, the variation shown may be comprised of afirst flexible layer and a second flexible layer positioned opposite tothe first layer such that a securement layer is formed therebetween andthe first and second layers are free to slide relative to one another.The first and second layers may be secured or otherwise sealed to oneanother around their periphery such that the securement layer between isformed into an air-tight chamber in fluid communication with each of theone or more suction openings. The securement layer may be filledcompletely or at least partially with a material which restricts thesliding movement between the first and second layers such as a screen,mesh, beads, grooves, channels which are transverse or angled relativeto one another, projections on opposed surfaces, etc. or any substanceor feature which increases the frictional resistance between the firstand second layers. In the event that a mesh layer is used as asecurement layer, there is no minimum thickness or porosity that themesh may have so long as the mesh provides sufficient frictionalresistance to movement between the first and second layers whencollapsed by the vacuum force.

During initial positioning of the substrate against a tissue region, thefirst and second layers may freely slide relative to one another as wellas relative to the securement layer thereby allowing for the substrateto conform against the anatomy of the underlying adhered tissue. Once avacuum force is applied via a fluidly coupled vacuum line through thesubstrate, e.g., 600 to 650 mmHg, the one or more suction openings mayattach to the underlying tissue due to the negative pressure and thefirst and second layers may collapse upon or towards one another. Thepresence of the securement layer may increase the frictional resistancebetween the contacting inner surfaces of the first and second layersagainst one another and against the securement layer such that thesubstrate may become frozen in its reconfigured shape. If the substratewere reconfigured to conform to an anatomy of the underlying tissue orreconfigured into another shape, application of the negative pressuremay collapse the first and second layers such that substrate maymaintain its configuration while the vacuum is applied. If the substratewere adhered against the underlying tissue in a flattened configuration,application of the negative pressure may collapse the first and secondlayers such that the flattened configuration is maintained. Once thevacuum force is released or the pressure increased, the first and secondlayers may release from one another and from the securement layerenabling the substrate to release from the tissue and revert to itsflexible shape for removal or attachment to the tissue or to anotherregion of tissue.

The substrate may further define one or more channels or openings whichmay extend from a periphery of the substrate towards theinsufflation/trocar positioning guide to further provide for flexibilityof the substrate. Moreover, the trocar positioning guide may projectfrom the substrate, e.g., transversely or at an angle relative to thesubstrate, such that the positioning guide comprises a trocar channelwhich defines a lumen passing through the substrate to allow for thetrocar to pass through and into the underlying tissue. The positioningguide may also have a shoulder which projects radially from a proximalportion of the trocar channel which provides a handle for ease ofmanipulation and adjustment of the positioning guide and substrate bythe user and which also facilitates the insertion of the trocar into thetrocar channel. The trocar channel may further define an opening or slitalong the channel to provide for angled positioning of the trocar in acontrolled manner relative to the substrate and trocar positioningguide. Hence, the width of the opening or slit along the trocar channelmay have a dimension which is the same or slightly larger than thediameter of the trocar itself. Moreover, there may be a plurality ofinterchangeable guides for specific applications or procedures toimprove access or retraction such as retraction for tissue positioning,insufflation, trocar placement, or facia closure.

In one example of use, the platform may be positioned over a tissueregion of interest to be treated and the one or more suction openingsmay be placed into contact upon the tissue, e.g., skin surface, suchthat the positioning guide projects away from the skin surface. A vacuumforce may be actuated via a pump fluidly coupled via one or more fluidlines and applied through the substrate such that the one or moresuction openings create an adhesion force to secure the substrate uponthe skin surface. The substrate may be positioned to ensure that theopening of the positioning guide is aligned directly over the portion ofthe tissue to be pierced by the trocar.

With the positioning platform so positioned, the trocar may be advancedthrough the positioning guide with an insertion force applied to thetrocar and towards the tissue region to be entered. Simultaneously, acounterforce may be applied directly to the positioning guide in theopposite direction of the insertion force. With the tissue adhered tothe one or more suction openings and with the counterforce applied inthe opposing direction of the insertion force from the trocar, thetissue may be maintained in a relatively neutral state as the trocar isinserted through the skin surface and further into the tissue. That is,the tissue may be prevented from dimpling or collapsing further into thebody as the trocar is initially inserted and advanced into the tissue.This may further prevent the inadvertent insertion, damage, or nickingof tissue structures during trocar insertion. After the trocar has beeninserted into the tissue, the vacuum level may be optionally reducedfrom an initial level.

Another variation of the positioning platform may utilize a substrateformed from any number of biocompatible flexible materials (e.g.,polyethylene, polyvinyl, silicone, etc.) which are configured to have anadhesive surface for temporary securement to a skin surface. With thepositioning guide extending from the first surface, the second surfacemay be coated or infused with any number of biocompatible agents oradhesives (e.g., acrylates, cyanoacrylates, silicone, polyurethane,epoxy, etc.) which may temporarily adhere the second surface to thetissue surface. While the substrate may not be adhered via a vacuumforce which collapses layers of the substrate to maintain a shape orconfiguration, the substrate may still be used to retract the tissueonce adhered as well as reconfigure the tissue, for example, by manuallyreconfiguring the tissue region. Furthermore, this variation may alsooptionally incorporate a pivoting or redirectable positioning guide withthe substrate.

Yet another variation may utilize a handle secured to the first side ofthe substrate. This variation may omit a trocar positioning guide andopening such that positioning platform is used as a tissue retractor ormanipulator once the substrate is adhered to the tissue surface. Thehandle may be configured into any number of configurations which allowfor the user to manipulate the substrate into various positions.

Yet another variation may have a substrate incorporate a handleprojecting from a first side of the substrate. The second surface of thesubstrate may be configured to have, e.g., an adhesive (as describedherein), for temporary attachment to a tissue surface. The interior ofthe substrate may be filled with a particulate material such as beads(made from any variety of materials such as plastics, polymers, etc.)which are free to move relative to one another and contained between thefirst layer and second layer of the substrate. The beads are freelymovable prior to the interior being collapsed by a vacuum force suchthat the substrate, when placed upon a tissue surface, may conform tothe anatomy. Once adhered to the tissue surface in its unconstrainedconfiguration where the beads are freely movable, the substrate may bereconfigured via manipulation of the handle, for instance, to retractthe tissue region of interest. The vacuum force may be applied to theinterior of the substrate while holding the handle in its reconfiguredshape until the layers collapse against one another and upon thecontained beads. The beads may collapse against one another increasingthe frictional resistance and forcing the substrate to maintain itsreconfigured shape and also forcing the adhered tissue to maintain thesame reconfigured shape, e.g., remaining in a retracted state. Once thevacuum force is removed and air is allowed to re-enter the interior ofsubstrate, the substrate may relax is shape and allow for the adheredtissue to flatten or return to its initial shape.

One variation for an apparatus for positioning an instrument maygenerally comprise a substrate having a first surface and a secondsurface opposite to the first surface, an instrument positioning guideprojecting from the first surface of the substrate, and one or moresuction assemblies positioned along the second surface and in fluidcommunication with an interior of the substrate, wherein the one or moresuction assemblies are attachable to a tissue region via a vacuum forceapplied through the one or more suction assemblies. The apparatus mayhave the substrate configured to maintain a predetermined configurationwhen the vacuum force is applied.

One variation for a method of positioning the instrument may generallycomprise positioning a second surface of a substrate in proximity to atissue surface, where the second surface is opposite to a first surfaceof the substrate, adhering one or more suction assemblies positionedalong the second surface to the tissue surface via a vacuum forceapplied through the one or more suction assemblies, wherein the one ormore suction assemblies are in fluid communication with an interior ofthe substrate, advancing an instrument through or along an instrumentpositioning guide projecting from the first surface of the substrate andinto the tissue surface, and applying a counterforce to the substratewhile advancing the instrument into the tissue surface.

Another variation for a method of positioning the instrument maygenerally comprise positioning a second surface of a substrate inproximity to a tissue surface, where the second surface is opposite to afirst surface of the substrate, adhering one or more suction assembliespositioned along the second surface to the tissue surface via a vacuumforce applied through the one or more suction assemblies, wherein theone or more suction assemblies are in fluid communication with aninterior of the substrate, reconfiguring a shape of the substrate whileadhering the tissue surface to the one or more suction assemblies suchthat the tissue surface is reconfigured accordingly, advancing aninstrument through or along an instrument positioning guide projectingfrom the first surface of the substrate and into the tissue surface, andapplying a counterforce to the substrate while advancing the instrumentinto the tissue surface.

Yet another apparatus for retracting a tissue region may generallycomprise a substrate having a first surface and a second surfaceopposite to the first surface, one or more suction assemblies positionedalong the second surface and in fluid communication with an interior ofthe substrate, wherein the one or more suction assemblies are attachableto the tissue region via a vacuum force applied through the one or moresuction assemblies, and wherein the substrate is configured to maintaina predetermined configuration when the vacuum force is applied.

Yet another method of positioning an instrument may generally comprisepositioning a second surface of a substrate in proximity to a tissuesurface, where the second surface is opposite to a first surface of thesubstrate, adhering one or more suction assemblies positioned along thesecond surface to the tissue surface via a vacuum force applied throughthe one or more suction assemblies, wherein the one or more suctionassemblies are in fluid communication with an interior of the substrate,and maintaining a first configuration of the substrate via the vacuumforce such that the adhered tissue surface conforms to the firstconfiguration.

For all embodiments, it is anticipated that the amount of vacuumrequired may vary upon the procedure. For example, a higher vacuum levelmay be required during retraction while a lower vacuum may be requiredfor maintaining position on the tissue, and/or maintaining tissue/trocarorientation. This may be achieved through, e.g., direct adjustment ofthe vacuum level at the source or a user activated valve which may beintegrated into the device itself that may provide variable or presetlevels of vacuum.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of one variation of the trocarpositioning and retraction platform.

FIGS. 2A and 2B show perspective and side views of the trocarpositioning and retraction platform with the trocar angled relative tothe platform.

FIGS. 3A to 3C show side views of one example of how the platform may beused to provide a counterforce to the trocar during insertion throughtissue.

FIG. 3D shows a side view of the platform assembly in communication witha valve which is controllable to alter the suction force applied throughthe platform.

FIGS. 4A and 4B show side views of another example of how the platformmay be used as a retraction device to hold a tissue region in place.

FIGS. 5A and 5B show various perspective views of yet another variationof the trocar positioning and retraction platform.

FIGS. 6A and 6B show various perspective views of yet another variationof a platform configured for tissue retraction and manipulation.

FIG. 7 shows a detail side view of the platform illustrating an exampleof the securement mechanism.

FIGS. 8A and 8B show various perspective views of yet another variationof a platform configured for tissue retraction and manipulation.

FIGS. 9A and 9B show top and side views of yet another variation of aplatform configured for tissue retraction and manipulation.

FIG. 9C shows a side view of the platform of FIGS. 9A and 9Billustrating how the platform may be reconfigured to maintain its shapeagainst a tissue region.

FIGS. 10A and 10B show various perspective views of an individualsuction mechanism for temporary adherence to a tissue region.

FIG. 11 shows a cross-sectional side view of the suction mechanism ofFIGS. 10A and 10B.

FIGS. 12A and 12B show various perspective views of another variation ofan individual suction mechanism for temporary adherence to a tissueregion.

FIG. 13 shows a cross-sectional side view of the suction mechanism ofFIGS. 12A and 12B.

FIG. 14 shows a cross-sectional side view of another variation of anindividual suction mechanism.

FIG. 15 shows a side view of the platform used in combination with aneedle.

FIG. 16 shows a side view of the platform used in combination with animaging instrument such as a laparoscope.

FIG. 17 shows a perspective view of the platform having an integratedultrasound transducer to provide imaging while in use with the platform.

DETAILED DESCRIPTION OF THE INVENTION

In accessing regions within a subject's body, trocar devices aretypically used to provide access for various surgical instruments suchas laparoscopic instruments. During the initial insertion of the trocarthrough the skin and tissue layers, there is risk that the trocar mayunintentionally damage underlying tissue. Moreover, once insertedthrough the skin surface and into the patient body, the trocar and/orinstruments may be desirably repositioned or angled relative to theunderlying tissue. Additionally, during a surgical procedure, the tissueunderlying the skin may be desirably retracted or moved temporarily tofacilitate the procedure being performed upon the subject.

One variation of a trocar positioning platform which may also be usedfor tissue retraction or positioning is shown in the perspective view ofFIG. 1 . The positioning platform 10 is shown as substrate 12 having afirst side upon which a trocar positioning guide 26 may extend and asecond side which is configured to apply a releasable vacuum through oneor more suction openings 20 which may be adhered upon a tissue surfacefor temporary securement. A pump or negative pressure mechanism locatedremotely from the substrate 12 may be fluidly coupled to the substrate12 via one or more fluid lines for providing the vacuum force. The oneor more suction openings 20 may be distributed over the substrate 12 ina uniform manner, an arbitrary manner, or in any number of predeterminedspecified configurations. The one or more suction openings 20 may eachdefine a chamber defined by an individual suction assembly 22. While thenumber of suction openings 20 may vary from one to a plurality ofopenings, one variation of the substrate 12 may incorporate, e.g.,twenty-one to twenty-five suction openings.

The substrate 12 may be formed to have any variety of configurations(e.g., circular, elliptical, rectangular, pentagonal, hexagonal,octagonal, etc.) so long as the substrate 12 is desirably positionableupon a tissue region of interest. While the substrate 12 may be formedin a number of different configurations, the variation shown may becomprised of a first flexible layer 14 and a second flexible layer 16positioned opposite to the first layer 14 such that a securement layer18 is formed therebetween and the first and second layers 14, 16 arefree to slide relative to one another. The first and second layers 14,16 may be secured or otherwise sealed to one another around theirperiphery such that the securement layer 18 between is formed into anair-tight chamber in fluid communication with each of the one or moresuction openings 20. The securement layer 18 may be filled completely orat least partially with a material which restricts the sliding movementbetween the first and second layers 14, 16 such as a screen, mesh,beads, grooves, channels which are transverse or angled relative to oneanother, projections on opposed surfaces, etc. or any substance orfeature which increases the frictional resistance between the first andsecond layers 14, 16. In the event that a mesh layer is used as asecurement layer 18, there is no minimum thickness or porosity that themesh may have so long as the mesh provides sufficient frictionalresistance to movement between the first and second layers 14, 16 whencollapsed by the vacuum force.

During initial positioning of the substrate against a tissue region, thefirst and second layers 14, 16 may freely slide relative to one anotheras well as relative to the securement layer 18 thereby allowing for thesubstrate 12 to conform against the anatomy of the underlying adheredtissue. Once a vacuum force is applied via a fluidly coupled vacuum linethrough the substrate 12, e.g., 600 to 650 mmHg, the one or more suctionopenings 20 may attach to the underlying tissue due to the negativepressure and the first and second layers 14, 16 may collapse upon ortowards one another. The presence of the securement layer 18 mayincrease the frictional resistance between the contacting inner surfacesof the first and second layers 14, 16 against one another and againstthe securement layer 18 such that the substrate 12 may become frozen inits reconfigured shape. If the substrate 12 were reconfigured to conformto an anatomy of the underlying tissue or reconfigured into anothershape, application of the negative pressure may collapse the first andsecond layers 14, 16 such that substrate 12 may maintain itsconfiguration while the vacuum is applied. If the substrate 12 wereadhered against the underlying tissue in a flattened configuration,application of the negative pressure may collapse the first and secondlayers 14, 16 such that the flattened configuration is maintained. Oncethe vacuum force is released or the pressure increased, the first andsecond layers 14, 16 may release from one another and from thesecurement layer 18 enabling the substrate 12 to release from the tissueand revert to its flexible shape for removal or attachment to the tissueor to another region of tissue.

The substrate 12 may further define one or more channels or openings 24which may extend from a periphery of the substrate 12 towards the trocarpositioning guide 26 to further provide for flexibility of the substrate12. Moreover, the trocar positioning guide 26 may project from thesubstrate 12, e.g., transversely or at an angle relative to thesubstrate 12, such that the positioning guide 26 comprises a trocarchannel 30 which defines a lumen 32 passing through the substrate 12 toallow for the trocar 36 to pass through and into the underlying tissue.The trocar 36 may be seen extending through the trocar channel 30 suchthat the trocar distal tip 38 has been pushed through past the substrate12 and into the underlying tissue. The positioning guide 26 may alsohave a shoulder 28 which projects radially from a proximal portion ofthe trocar channel 30 which provides a handle for ease of manipulationand adjustment of the positioning guide 26 and substrate 12 by the userand which also facilitates the insertion of the trocar 36 into thetrocar channel 30. The trocar channel 30 may further define an openingor slit 34 along the channel 30 to provide for angled positioning of thetrocar 36 in a controlled manner relative to the substrate 12 and trocarpositioning guide 26. Hence, the width of the opening or slit 34 alongthe trocar channel 30 may have a dimension which is the same or slightlylarger than the diameter of the trocar 36 itself.

FIGS. 2A and 2B show perspective and side views of the substrate 12 andthe trocar 36 angled relative to the substrate 12. With the substrate 12adhered against the tissue surface, the trocar 36 may be inserted at anangle relative to the substrate 12 and/or tissue surface or the trocar36 may be angled after insertion such that the body of the trocar 36 ispositioned within or along the opening or slit 34 defined along thechannel 30. In either case, the trocar 36 may be positioned at an angleΘ such that a longitudinal axis of the trocar 36 is angled relative to alongitudinal axis of the positioning guide 26. The angle Θ may rangeanywhere from, e.g., 0 degrees to close to 90 degrees, depending uponthe desired positioning of the trocar 36. While the positioning guide 26is illustrated as having a channel 30, other variations of thepositioning guide 26 may include other pivoting mechanisms, such as aball pivot, etc.

One example is illustrated in the side views of FIGS. 3A to 3C showinghow the trocar positioning platform 10 may be used for tissue retractionduring insertion of a trocar 36 into a tissue region of interest. Asshown in FIG. 3A, the platform 10 may be positioned over a tissue regionof interest to be treated and the one or more suction openings 20 may beplaced into contact upon the tissue, e.g., skin surface S, such that thepositioning guide 26 projects away from the skin surface S, as shown. Avacuum force may be actuated via pump 41 fluidly coupled via one or morefluid lines 43 and applied through the substrate 12 such that the one ormore suction openings 20 create an adhesion force 40 to secure thesubstrate 12 upon the skin surface S. The substrate 12 may be positionedto ensure that the opening of the positioning guide 26 is aligneddirectly over the portion of the tissue to be pierced by the trocar 36.

With the positioning platform 10 so positioned, the trocar 36 may beadvanced through the positioning guide 26 with an insertion force 44applied to the trocar 36 and towards the tissue region to be entered.Simultaneously, a counterforce 42 may be applied directly to thepositioning guide 26 in the opposite direction of the insertion force44, as shown in FIG. 3B. With the tissue adhered to the one or moresuction openings 20 and with the counterforce 42 applied in the opposingdirection of the insertion force 44 from the trocar 36, the tissue maybe maintained in a relatively neutral state as the trocar 36 is insertedthrough the skin surface S and further into the tissue, as shown in FIG.3C. That is, the tissue may be prevented from dimpling or collapsingfurther into the body as the trocar 36 is initially inserted andadvanced into the tissue. This may further prevent the inadvertentinsertion, damage, or nicking of tissue structures during trocar 36insertion. After the trocar 36 has been inserted into the tissue, thevacuum level may be optionally reduced from an initial level.

As the trocar 36 is inserted into and through the tissue, the relativelylarge diameter of the trocar 36 can “tent” the tissue inwardly into thepatient when the point of the trocar 36 is pressed through the abdomen.The amount of tenting may dramatically increase the force required toplace the trocar 36 but because the practitioner not only lifts thetissue (to also help move any internal organs out of the way) tenting ofthe tissue is also minimized thus requiring less force to insert thetrocar 36 and also reducing the possibility of over inserting the trocar36 into the patient body as the trocar 36 breaks into the peritoneum.

In the event that a pivoting positioning guide (as described herein) isutilized with the substrate 12, the positioning guide may be reorientedbefore, during, or after insertion and/or advancement of the trocar 36into the tissue to redirect the trocar insertion into the tissue.

In one variation, the trocar 36 may be advanced using one hand of theuser while the positioning guide 26 is retracted by the other hand ofthe user. In other variations, both the insertion and advancement of thetrocar 36 as well as the retraction of the positioning guide 26 may beperformed by a single hand of the user. In yet other variations, boththe insertion of the trocar 36 and the retraction of the positioningguide 26 may be performed by different users.

The tissue surface S is shown in the example as remaining in arelatively flattened state during trocar 36 insertion and advancement.However, in other variations, the adhered tissue may be retracted by thepositioning platform 10 and conformed by substrate 12 into a differentconfiguration, such as a retracted configuration, which may then bemaintained by the substrate 12 locking its configuration. With thealtered tissue configuration, the same steps of trocar 36 insertion andadvancement with retraction of the positioning guide 26 may beperformed, as described.

While the adhesion force 40 created by pump 41 to secure the platform 10to the skin surface S may be maintained at a constant level prior to,during, and/or after a procedure, the adhesion force may be optionallyvaried as well. FIG. 3D illustrates a side view of the positioning guide26 with one or more fluid lines 43 fluidly coupling the platform 10 tothe pump 41, as previously described, but this variation may incorporatea valve 45, such as a check valve or variably controllable valve, alongthe one or more fluid lines 43 to control the level of suction forceupon the skin surface S. The valve 45 may be manually controlled or thevalve 45 may be optionally controlled by a controller 47 incommunication with valve 45 and pump 41. The controller 47 may beprogrammed, for instance, to open and/or close the valve 45 atpredetermined pressure levels or the valve 45 may be programmed to openand/or close at predetermined points of a procedure or when actuated bythe user.

In yet another variation, a maximum first vacuum level may be appliedduring insertion of the trocar or other instrument such that theplatform 10 provides for an optimal lifting force of the tissue. Oncethe insertion through the tissue has been completed, the vacuum forceapplied by platform 10 may be automatically adjusted down to a lowersecond vacuum level which may also prevent the formation of any bruisesor hematomas which may result from the platform 10 being adhered to theskin surface.

An example is illustrated in the side views of FIGS. 4A and 4B whichshow the positioning platform 10 placed against the tissue surface andadhered to the tissue while in a first configuration. In this variation,the positioning platform 10 may have a flattened configuration relativeto the skin surface. With the one or more suction openings 20 adhered tothe tissue via the adhesion force 40, the positioning guide 26 and/orsubstrate 12 may be retracted or moved from its initial position suchthat the positioning platform 10 conforms into a second configuration 50causing the underlying adhered tissue to conform accordingly, as shownin FIG. 4B. The substrate 12 may be conformed, as described herein, tomaintain this second configuration 50 to hold or maintain the adheredskin in a retracted configuration. The positioning platform 10 may beused accordingly, e.g., as an external tissue retractor, for any numberof procedures such as for breast retraction.

Another variation of the positioning platform is illustrated in theperspective views of FIGS. 5A and 5B. In this variation, the substrate60 may be formed from any number of biocompatible flexible materials(e.g., polyethylene, polyvinyl, silicone, etc.) which are configured tohave an adhesive surface 62 for temporary securement to a skin surface.With the positioning guide 26 extending from the first surface, thesecond surface 62 may be coated or infused with any number ofbiocompatible agents or adhesives (e.g., acrylates, cyanoacrylates,silicone, polyurethane, epoxy, etc.) which may temporarily adhere thesecond surface 62 to the tissue surface. While the substrate 60 may notbe adhered via a vacuum force which collapses layers of the substrate tomaintain a shape or configuration, the substrate 60 may still be used toretract the tissue once adhered as well as reconfigure the tissue, forexample, by manually reconfiguring the tissue region. Furthermore, thisvariation may also optionally incorporate a pivoting or redirectablepositioning guide 26 with the substrate 60.

Yet another variation is shown in the perspective views of FIGS. 6A and6B which illustrate a substrate 70 having the one or more suctionopenings 20 along a second side of the substrate 70 and a handle 74secured to the first side of the substrate 70. A vacuum tube attachment72 is illustrated as being fluidly coupled along the first side of thesubstrate 70. This variation may omit a trocar positioning guide 26 andopening such that positioning platform is used as a tissue retractor ormanipulator once the substrate 70 is adhered to the tissue surface. Thehandle 74 may be configured into any number of configurations whichallow for the user to manipulate the substrate 70 into variouspositions.

FIG. 7 shows a partial cross-sectional side view of the variation ofFIGS. 6A and 6B to illustrate how the first layer 76 and the secondlayer 78 may be sealed to one another, e.g., around their periphery, toform the securement layer 80 within. As described above, the securementlayer 80 may contain any number of substances or features which aredesigned to increase a frictional resistance between the first andsecond layers 76, 78 when the layers are collapsed against one another.Each of the one or more suction openings 20 may be seen as extendingfrom the second surface and are each in fluid communication with thesecurement layer 80 between the first and second layers 76, 78.

FIGS. 8A and 8B show perspective views of yet another variation of asubstrate 90 which may be similar to the substrate 60 described herein.This variation may incorporate the handle 74 with the substrate 90 sothat the positioning platform may be utilized, e.g., as a tissueretractor or manipulator, once adhered to the tissue surface.

Yet another variation is shown in the top and side views of FIGS. 9A to9C which show a positioning platform configured for tissue retractionand/or manipulation. The substrate 100 in this variation may incorporatea handle 102 projecting from a first side of the substrate 100. A vacuumtube attachment 104 is also shown projecting from the first side andwhich is in fluid communication with the interior of the substrate, asshown in the top view of FIG. 9A. The second surface of the substrate100 may be configured to have, e.g., an adhesive (as described herein),for temporary attachment to a tissue surface. The side view of FIG. 9Bshows a detail cross-sectional view of an interior of the substrate 100which may be filled with a particulate material such as beads 106 (madefrom any variety of materials such as plastics, polymers, etc.) whichare free to move relative to one another and contained between the firstlayer 101 and second layer 103 of the substrate 100. As illustrated, thebeads 106 are shown to be freely movable prior to the interior beingcollapsed by a vacuum force such that the substrate 100, when placedupon a tissue surface, may conform to the anatomy. Once adhered to thetissue surface in its unconstrained configuration where the beads 106are freely movable, the substrate 100 may be reconfigured viamanipulation of the handle 102, for instance, to retract the tissueregion of interest. The vacuum force may be applied to the interior ofthe substrate 100′ while holding the handle 102 in its reconfiguredshape until the layers 101, 103 to collapse against one another and uponthe contained beads 106, as shown in FIG. 9C. The beads 106 may collapseagainst one another increasing the frictional resistance and forcing thesubstrate 100′ to maintain its reconfigured shape and also forcing theadhered tissue to maintain the same reconfigured shape, e.g., remainingin a retracted state. Once the vacuum force is removed and air isallowed to re-enter the interior of substrate 100, the substrate 100 mayrelax is shape and allow for the adhered tissue to flatten or return toits initial shape.

Turning now to the structure of the individual suction assembly 22,FIGS. 10A and 10B show various perspective views of one variation. Thesuction assembly 22 may be formed to have a suction housing 110 whichprojects to form a suction chamber 112 for placement against the surfaceof the tissue to be adhered. The suction housing 110 may define anynumber of cross-sectional shapes suitable for forming the suctionchamber 112 (e.g., circular, elliptical, rectangular, polygonal, etc.)and may project distally from a lower housing 114 having a lowershoulder 116 which projects radially to form a lower periphery of thelower housing 114. An upper housing 118 may be attached to the lowerhousing 114 and may similarly have an upper shoulder 120 which projectsradially to form an upper periphery of the upper housing 118. Asubstrate attachment portion 122 may be formed between the lowershoulder 116 and the upper shoulder 120 for attachment to the first andsecond layers of the substrate. Additionally, one or more fluid channels124 may be defined around the periphery of the substrate attachmentportion 122 for providing fluid communication with the interior of thesecurement layer 18. While the lower housing 114 and upper housing 118are illustrated as having a circularly-shaped form annularly relative tothe suction housing 110, the lower housing 114 and upper housing 118 maybe formed to have other shapes or configurations.

FIG. 11 illustrates a cross-sectional side view of a suction assemblyattached to a substrate. As shown, the first layer 14 may be attachedabout the upper shoulder 120 forming a fluid-tight seal and the secondlayer 16 may be attached about the lower shoulder 116 also forming afluid-tight seal while the one or more fluid channels 124 defined aboutthe periphery of the substrate attachment portion 122 remain in fluidcommunication with the interior of the securement layer 18. A housingchamber 134 may be formed between a floor 130 of the lower housing 114and the upper housing 118 with a valve 136, e.g., umbrella valve, whichmay be biased towards the floor 130 to maintain the valve 136 in aclosed configuration against the floor 130. A retaining member 138projecting from the valve 136 may extend through an opening 132 definedthrough the floor 130 and partially into the suction chamber 112. Theretaining member 138 may be configured to include a widened, retainingportion which allows for the valve 136 to move between an open andclosed configuration until the widened portion abuts against the opening132 to limit the amount that the valve 136 may open.

During use when the vacuum force is applied to the substrate, the air orgas within the securement layer 18 and also within the housing chamber134 may evacuate urging the valve 136 into an open configuration wherethe valve 136 extends into the interior of the housing chamber 134 whilelimited in travel by the widened, retaining portion of the retainingmember 138. With the valve 136 thus opened, the air or gas within thesuction chamber 112 may also evacuate via one or more openings definedthrough the floor 130 and into and through the housing chamber 134 andout through one or more fluid channels 124 causing the suction housing110 to adhere to the underlying contacted tissue surface due to thenegative pressure created within the suction chamber 112. As the valve136 may be optionally biased to close against the floor 130, once thesuction pressure has reached an equilibrium between the housing chamber134 and suction chamber 112 (or when the suction pressure has droppedbelow the biased closing force of the valve 136), the valve 136 mayclose against the floor 130 to seal the suction chamber 112 from thehousing chamber 134. In this manner, the suction securement between thesuction housing 110 and the adhered tissue surface may be maintainedindividually between each of the suction assemblies 22 and tissuesurface. This may be especially helpful in the event that vacuumpressure is lost within the securement layer 18 during a procedure aseach of the individual suction assemblies 22 may maintain suctionadherence to the tissue surface independently of one another.

Another variation of the suction assembly 140 is shown in the variousperspective views of FIGS. 12A and 12B which illustrate a suctionhousing 142 defining a suction chamber 144 similarly formed from a lowerhousing 146 having a lower shoulder 148. An upper housing 150 having anupper shoulder 152 may attach to the lower housing 146 and form asubstrate attachment portion 154 about a periphery of the housingassembly. Also, one or more fluid channels 156 may be defined about theperiphery of the substrate attachment portion 154.

As shown in the cross-sectional side view of FIG. 13 , the manner inwhich the valve 166 is designed and positioned within the housingchamber 164 may allow for the height between the lower shoulder 148 andupper shoulder 152 to be reduced relative to previous embodiments whilestill allowing for fluid communication through the one or more fluidchannels 156 with the securement layer 18. This reduced height may alsoallow for a substrate which is relatively thinner. The valve 166 may bebiased to remain in a closed configured where an outer sealing surface170 of sealing member 168 is urged against an opening 162 defined overthe floor 160 of the lower housing 146. The sealing member 168 may beconfigured in a conical shape projecting from the valve body such thatwhen the vacuum is applied to the substrate, the valve 166 may be urgedinto its open configuration such that the sealing surface 170 is liftedaway from the opening 162 allowing for the negative pressure within thesuction chamber 144 to adhere the underlying tissue surface to thesuction housing 142. As described above, when the suction pressure hasreached an equilibrium between the housing chamber 164 and suctionchamber 144 (or when the suction pressure has dropped below the biasedclosing force of the valve 166), the valve 166 may close against thefloor 160 to seal the suction chamber 144 from the housing chamber 164.This allows for the individual suction assembly to adhere to the tissuesurface.

As previously described, the vacuum tube attachment may be coupled tothe substrate for providing fluid communication between a pump and thesecurement layer of the substrate and suction assemblies. While thevacuum tube attachment may be coupled at any location over thesubstrate, the attachment may also be coupled to one of the suctionassemblies. FIG. 14 shows a cross-sectional side view of one variationwhere a vacuum tube 182 having a lumen 184 defined through the length ofthe tube 182 may be attached directly to at least one of the suctionassemblies. A distal end of the tube 182 may be attached to the housingof the suction assembly such that the lumen 184 may be fluidly coupleddirectly to the housing chamber 164. A proximal end of the tube 182 maybe fluidly attached to a fluid line for communication with a pump suchthat when the pump is actuated, the vacuum force may be applied throughthe lumen 184 and the attached suction assembly. As the suction assemblyis fluidly coupled with the securement layer and the other suctionassemblies, the vacuum force may applied to the entire substrate andsuction assemblies accordingly.

Turning now to other uses or implementations of the positioning platform10, various laparoscopic procedures may be facilitated using any of theplatform embodiments described herein. One particular procedure mayinvolve the use of the platform for establishing a pneumoperitonealcavity in a patient via insufflation in preparation for an abdominal (orother cavity) procedure. The practitioner typically identifies alocation along the patient body, such as the abdomen, where aninstrument such as a Veress needle may be penetrated through the skinuntil the tip reaches just inside the peritoneum. The practitioneroftentimes inserts the needle blindly into the patient body which mayresult in an unintended injury. For instance, if a portion of the bowelis adhered to the inner wall of the peritoneum, the needle may beinserted over the adhesion resulting in the bowel being pierced ornicked.

Once the needle has been suitably positioned within the patient body,the cavity is then inflated through the needle and a primary trocar maybe inserted, also blindly, into the peritoneum. For patients withadhesions, a similar complication as with the needle insertion can occurwith the trocar. Another instrument such as a laparopscopic camera maythen be inserted into the peritoneum through the primary trocar, forinstance, to facilitate the insertion of additional trocars into thepatient under direct vision to reduce the risk of internal damage.

With the positioning platform 10 adhered to the skin surface S, theplatform 10 may be used to lift the region of tissue of tissue where theneedle and/or trocar will be inserted to facilitate the separation ofany bowel tissue from the interior of the abdominal wall. Lifting of thetissue area may also help the practitioner to assess for the existenceof any adhesions prior to the insertion of the needle and/or trocar.

An example is shown in the side view of FIG. 15 which illustrates theapplication of the platform 10 against the skin surface S which may belifted away from the patient in order to lift the adhered tissue andprovide feedback as to the presence of any adhesions. Once theassessment has been made, the needle 190 may be inserted throughpositioning guide 26 until the piercing tip 192 of the needle or blunttip 194 has been inserted past the interior tissue wall away fromadhesions. Alternatively, the platform 10 may be removed from the tissueregion once the assessment has been completed with the platform 10 andthe needle 190 may be inserted directly into and through the skinsurface S.

In other variations, the platform 10 may be utilized directly with animaging instrument such as a laparoscope 200, as shown in the side viewof FIG. 16 . After trocar insertion through the skin surface S, thetrocar may be removed leaving the cannula sleeve 202 in place throughthe tissue region. The laparoscope 200 may be inserted, e.g., directlythrough the cannula sleeve 202 in order to provide for directvisualization within the body cavity.

In yet another variation, the platform 10 may be used in combinationwith an imaging instrument such as an ultrasound transducer 212 whichmay be in communication with either a controller 47 (as previouslydescribed) or a separate ultrasound controller 214, as shown in theperspective view of FIG. 17 . The ultrasound transducer 212 may be usedto determine, e.g., whether any adhesions are present underlying theskin surface prior to the application of the platform 10 against thetissue surface. The ultrasound transducer 212 may be initially appliedto the skin and then removed to allow for the use of the platform 10 butin other variations, the ultrasound transducer 212 may be incorporateddirectly with the platform 10. One variation is shown where one or moreopenings 210 may be formed through the platform 10 next to positioningguide 26 where an ultrasound transducer 212 may be integrated with theplatform 10 at one of the openings 210. The transducer 212 may be usedto provide for real time imaging of the tissue region directly below theplatform 10 prior to and during trocar insertion while the platform 10is adhered directly to the skin surface S.

When the trocar is removed, gas from the pneumoperitoneum can beevacuated through the opening or may leak through the opening. In orderto maintain a fluid-tight seal through the opening in the tissue orthrough the trocar to maintain the pneumoperitoneum, a seal or stoppermay be inserted to cover the trocar opening or directly over the tissueopening. At the end of the procedure, openings (e.g., larger than 12 mm)through the abdominal wall may be sutured closed.

The applications of the disclosed invention discussed above are notlimited to certain treatments or regions of the body but may include anynumber of other treatments and areas of the body. Modification of theabove-described methods and devices for carrying out the invention, andvariations of aspects of the invention that are obvious to those ofskill in the arts are intended to be within the scope of thisdisclosure. Moreover, various combinations of aspects between examplesare also contemplated and are considered to be within the scope of thisdisclosure as well.

What is claimed is:
 1. An apparatus for retracting a tissue region,comprising: a substrate having a first surface and a second surfaceopposite to the first surface; and a securement layer formed as aninterior chamber between the first surface and the second surface suchthat the first surface and second surface are free to slide relative toone another, wherein the substrate is configured to maintain apredetermined configuration when a vacuum force is applied to theinterior chamber through an opening defined in the substrate such thatthe vacuum force releasably adheres the second surface to a tissuesurface via one or more openings defined along the second surface andwhereby the first surface and the second surface are collapsed againstone another via the vacuum force and sliding movement is restrictedbetween the first surface and the second surface.
 2. The apparatus ofclaim 1 wherein the securement layer is configured to increase africtional resistance between an interior of the first and secondsurfaces when the vacuum force is applied such that the predeterminedconfiguration is maintained.
 3. The apparatus of claim 2 wherein thesecurement layer is comprised of a screen, mesh, beads, grooves,channels, or projections.
 4. The apparatus of claim 1 wherein thesubstrate comprises a flexible substrate which is reconfigurable toconform to the tissue surface.
 5. The apparatus of claim 1 furthercomprising one or more suction assemblies positioned along the secondsurface and in fluid communication with the interior chamber of thesubstrate.
 6. The apparatus of claim 5 wherein the one or more suctionassemblies each include a valve which is biased to maintain a closedconfiguration.
 7. The apparatus of claim 1 further comprising a handleextending from the first surface.
 8. The apparatus of claim 1 furthercomprising an ultrasound transducer integrated with the substrate andwhich is positioned to detect features within a region of tissue.